Ceftriaxone

ANDA 65263, held by Lupin. Ceftriaxone Sodium.

As of Nov 15, 2026, ANDA 65263 (Ceftriaxone), held by Lupin, was first approved by FDA on Sep 12, 2006, with 7 approved supplements and 0 published complete response letters.

First approved: Sep 12, 2006
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Sep 12, 2006	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
CeftriaxoneEQ 10GM BASE/VIAL · injectable;injection	Ceftriaxone Sodium	Discontinued

All 8 submissions, including labeling and manufacturing supplements


May 27, 2016	Supplement 13Labeling · Standard review	Approved	None posted
May 27, 2016	Supplement 14Labeling · Standard review	Approved	None posted
May 27, 2016	Supplement 15Labeling · Standard review	Approved	None posted
Jul 2, 2013	Supplement 11Labeling · Standard review	Approved	None posted
Jul 6, 2010	Supplement 8Labeling	Approved	None posted
Feb 2, 2010	Supplement 6Labeling	Approved	None posted
Jun 11, 2008	Supplement 3Labeling	Approved	None posted
Sep 12, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 65263
Drugs@FDA: Overview at FDA
Company: Lupin

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters